Study of Patient Use and Perception of the Travatan Dosing Aid
Primary Purpose
Glaucoma
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Fully functional monitoring device
Partially functional monitoring device
Non-functional monitoring device
Sponsored by

About this trial
This is an interventional supportive care trial for Glaucoma focused on measuring Travatan Dosing Aid, compliance monitoring dispenser
Eligibility Criteria
Inclusion Criteria:
- Open angle glaucoma or ocular hypertension
- Presently using Travatan eye drops
Exclusion Criteria:
- Allergy to prostaglandin
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Sham Comparator
Arm Label
1 Fully functional monitoring device
2 Partially functional monitoring device
3 Non-functional monitoring device
Arm Description
Fully functional monitoring device
Partially functional monitoring device
Non-functional monitoring device
Outcomes
Primary Outcome Measures
Assess patients' opinions regarding new Travatan Compliance Monitoring Dispenser
Secondary Outcome Measures
Pilot study of the impact of physician monitoring of compliance on patient compliance
Full Information
NCT ID
NCT00626067
First Posted
January 22, 2008
Last Updated
November 8, 2016
Sponsor
Wills Eye
Collaborators
Alcon Research
1. Study Identification
Unique Protocol Identification Number
NCT00626067
Brief Title
Study of Patient Use and Perception of the Travatan Dosing Aid
Official Title
Pilot Study of Patient Acceptance and Impact of the New Travatan™ Compliance Monitoring Dispenser (Travatan™ Dosing Aid)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wills Eye
Collaborators
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this study is to determine the opinions of patients who are given the Travatan Compliance Monitoring Dispenser to use to dispense their Travatan glaucoma drops.
Detailed Description
Patients enrolled in this study will use the new Travatan compliance monitoring dispenser for 6 weeks. Patients will be informed that some, but not all, patients' compliance will be monitored by the device. Patients are randomly assigned to one of three groups (proportionally in a 2/2/1 ratio):
Fully functional Travatan compliance monitor
Travatan compliance monitor with LCD display and alarms disabled, but compliance monitoring intact
Travatan compliance monitor with LCD display, alarms and compliance monitor disabled.
At end of study, patients fill out questionnaire assessing
Patient opinion regarding device: ease of use of new device; preference vs Travatan use without device, etc
patient's belief as to whether their compliance was monitored or not
Rates of adherence are compared across groups and with regard to patients' reported beliefs as to whether they were monitored.
The design of this study should allow the clinicians to ethically monitor compliance in patients who do and do not believe that they are being monitored. The use of monitoring devices without a functioning display and alarm should lead to some patients believing that they are not being monitored. As patients are told at the outset that they may or may not be monitored, this should be an ethically acceptable design. However, the collected data will allow a preliminary assessment of the impact of the patients' beliefs as to whether they are being monitored on their actual compliance, and hence an additional potential value of the device.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Travatan Dosing Aid, compliance monitoring dispenser
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 Fully functional monitoring device
Arm Type
Active Comparator
Arm Description
Fully functional monitoring device
Arm Title
2 Partially functional monitoring device
Arm Type
Active Comparator
Arm Description
Partially functional monitoring device
Arm Title
3 Non-functional monitoring device
Arm Type
Sham Comparator
Arm Description
Non-functional monitoring device
Intervention Type
Device
Intervention Name(s)
Fully functional monitoring device
Intervention Description
Pt received fully functional monitoring dispenser for use with their Travatan eye drops
Intervention Type
Device
Intervention Name(s)
Partially functional monitoring device
Intervention Description
Patient received a particually functional Travatan Compliance Monitoring Dispenser
Intervention Type
Device
Intervention Name(s)
Non-functional monitoring device
Intervention Description
Patient received a non functioning Travatan Compliance Monitoring Dispenser
Primary Outcome Measure Information:
Title
Assess patients' opinions regarding new Travatan Compliance Monitoring Dispenser
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Pilot study of the impact of physician monitoring of compliance on patient compliance
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Open angle glaucoma or ocular hypertension
Presently using Travatan eye drops
Exclusion Criteria:
Allergy to prostaglandin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan S. Myers, MD
Organizational Affiliation
Wills Eye Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
A Manuscript has been accepted and published in Patient Preference and Adherence.
Links:
URL
https://doi.org/10.2147/PPA.S114746
Description
Patient Preference and Adherence
Learn more about this trial
Study of Patient Use and Perception of the Travatan Dosing Aid
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